Events

Safety Alert for OPTEASE Retrievable Vena Cava Filter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cordis.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cordis optease retrievable vena cava filter medical device manufacturer, cordis (a johnson & johnson company), has initiated a field safety corrective action concerning optease retrievable vena cava filter. the affected catalogue numbers are 466f210a and 466f210b, and the affected lot numbers are 15960131 and below. cordis has identified a printing error on one unit of optease retrievable vena cava filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. the error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. implant of the opteaser retrievable vena cava filter with the hook oriented in the cranial direction can result in life threatening or serious injury including, but not limited to dissection, vessel perforation, migration of the filter with secondary damage to cardiac structures and ineffective pulmonary embolism prevention. there is no impact to the patient if the physician has successfully deployed and subsequently retrieved the filter. the manufacturer advises users to immediately identify, set aside and return all the affected products. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to website of the medicine and healthcare products regulatory agency, united kingdom: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

OPTEASE Retrievable Vena Cava Filter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cordis OPTEASE Retrievable Vena Cava Filter
  • Manufacturer
    Cordis

Manufacturer

Cordis